With FDA filing in sight, OptiNose preps novel nasal-spray gadget for 2017 rollout

Counting on a novel nasal-spray device to set it apart from its rivals, drug delivery specialist OptiNose is preparing to file its new chronic rhinosinusitis remedy for FDA approval by year's end, with an eye to a potential launch in 2017.

Citing recently released Phase III data, the Yardley, PA-based company says its OptiNose-delivered fluticasone spray is a potential blessing for patients suffering from chronic nasal and sinus problems. The drug itself isn’t exactly a novel one--it's a long-approved, widely used nasal steroid--but the delivery device is.

Unlike traditional nasal inhalers, OptiNose’s device uses two pathways, one into the mouth and the other into the patient’s nostrils. Patients insert the device and exhale to dispense a dose. Because the soft palate naturally seals off the nasal cavity during an exhale, the medication is blown into and trapped in the nasal cavity, where it's needed, rather than running down the throat.

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“We’re providing an efficient delivery system that delivers the medication much higher and deeper to the nose, … directly on the inflammatory tissue to get a better benefit,” OptiNose CEO Peter Miller said in an interview.

OptiNose has chalked up one success for its delivery device already: The privately held specialty pharma outlicensed its first product, a migraine drug using the same delivery system, to Avanir Pharmaceuticals in 2013, in a deal worth about $110 million. That med was approved by the FDA in January under the brand name Onzetra Xsail.

This time, the company intends to roll out its new product on its own, and it's in the process of staffing up for the job. The reason? A larger, more dissatisfied market. “Data suggests that there are about 20 million people suffering severely from CRS in the U.S., and about 10 million actively seeking treatment,” Miller said. “Many of these patients still report symptoms despite the availability of current treatments.”

To that end, OptiNose recently presented positive Phase III data on the drug-device combo, now dubbed EDS-FLU, showing significant improvement in both subjective and objective symptoms among patients using the product.

In one study, a randomized, double-blind, placebo-controlled trial on 323 patients with nasal polyps, the drug hit its primary and secondary endpoints after 16 weeks of treatment. Presented at the American Rhinologic Society’s annual meeting last month, the study showed that, for all three doses tested, EDS-FLU beat placebo at improving nasal congestion/obstruction and polyp grade. Most of the participants had previously used nasal steroids.

The company is planning to file for FDA approval by the end of this year and expects a reply from the agency by the third quarter of 2017.

The company is already gearing up for the potential launch. It recently recruited its first chief commercial officer--Tom Gibbs, former SVP and head of general medicines at Takeda Pharmaceuticals’ U.S. unit--to help lead the company's “transition from a development-based company to a commercial stage company,” Miller said in announcing the appointment.

Next up will be tripling the company’s small workforce to more than 50 full-timers at its soon-to-be-expanded headquarters. After the product wins an FDA nod, OptiNose plans to assemble a 100- to 150-person contract sales force, Miller said.

Even with the novel technology, an expanded team and $35 million in third-round VC funding, OptiNose has a tough task ahead: It will need to bite a meaningful share of the market from GlaxoSmithKline's blockbuster fluticasone spray Flonase, which the Big Pharma recently converted to over-the-counter status.

But given those many dissatisfied patients still looking for relief, Miller sees plenty of opportunity to do just that. In a survey of about 700 ENT specialists, OptiNose found that more than 75% of physicians are not satisfied with current treatment options, and among them, 75% attribute that to a lack of an efficient delivery system. And that, of course, is exactly what OptiNose is trying to improve, said Miller. EDS-FLU could provide “a new standard of care,” he said.